drugset / Trial / NCT00719875
HDAC Inhibitor Vorinostat (SAHA) With Capecitabine (Xeloda) Using a New Weekly Dose Regimen for Advanced Breast Cancer
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to determine the safety profile, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), of oral vorinostat in combination with oral capecitabine given on days 1-7 and 15-21 of a 28 day cycle in patients with advanced breast cancer, using RECIST criteria. This study was originally intended to be a phase 1/phase 2. The protocol was amended to make this study a phase 1 only.
Timeline
- Start
- 2008-12
- Primary completion
- 2013-06
- Completion
- 2013-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vorinostat | Small molecule | 200 mg | Oral |